Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT01577069
Status:
COMPLETED
Last Update Posted:
2016-06-22
First Post:
2012-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Factors of the Treatment Failure in Hepatitis C Virus (HCV) Infected Patients Treated With Telaprevir
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-21', 'studyFirstSubmitDate': '2012-04-12', 'studyFirstSubmitQcDate': '2012-04-12', 'lastUpdatePostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'virological resitance', 'timeFrame': '12 weeks after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis C', 'Direct Antiviral agent (DAA)', 'Ultra-deep pyrosequencing', 'Single polynucleotide polymorphisms', 'Treatment-resistant mutants', 'Hepatitis C Virus Protease Inhibitor'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to\n\n1- detect and quantify HCV-PI resistant mutants with ultra-deep pyrosequencing (UDPS) technology, 2 - detect SNPs in P-glyocoprotein and CYP3A genes, in HCV mono-infected patients under/after Telaprevir treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HCV mono-infected patients treated in the Hepatology Unit of Pr Victor de Lédinghen (Hôpital du Haut-Lévêque, Pessac)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HCV mono-infected subjects\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* HBV co-infection'}, 'identificationModule': {'nctId': 'NCT01577069', 'acronym': 'GENUPI', 'briefTitle': 'Predictive Factors of the Treatment Failure in Hepatitis C Virus (HCV) Infected Patients Treated With Telaprevir', 'organization': {'class': 'OTHER', 'fullName': 'Association HGE CHU Bordeaux Sud'}, 'officialTitle': 'Predictive Factors of the Treatment Failure in HCV Mono-infected Patients Treated With Pegylated-interferon/Ribavirin/Telaprevir.', 'orgStudyIdInfo': {'id': 'UDPS-100211'}}, 'contactsLocationsModule': {'locations': [{'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Hôpital du haut-Lévêque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}], 'overallOfficials': [{'name': 'Victor de lédinghen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association HGE CHU Bordeaux Sud', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}